Item nanme:Hydroxychloroquine sulfate tablets Item character:The product is white
Indication: Rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus erythematosus, and skin lesions caused or exacerbated by sunlight.
Item specifications:0.1g*14tab/box
Usage and dosage:The tablets were given orally.
Adults (including the elderly)
The first dose was 400mg per day. When the curative effect is not further improved, the dose can be reduced to 200 mg. If the treatment response is weakened, the maintenance dose should be increased to 400 mg per day. The minimum effective dose should not exceed 6.5mg/kg/day (calculated from ideal body weight rather than actual body weight) or 400mg / day, or even less.
children
The minimum effective dose should not exceed 6.5mg/kg/day (based on ideal body weight) or 400mg / day, or even less. It is forbidden for children under 6 years old, and 200mg tablet is not suitable for children under 35kg.
Take or drink milk at the same time.
Hydroxychloroquine has a cumulative effect, it takes several weeks to play its beneficial role, and mild adverse reactions may occur relatively early. If the rheumatic disease does not improve after 6 months of treatment, the treatment should be terminated. In the case of light sensitive diseases, treatment should only be given under maximum exposure to sunlight.
Adverse reactions Retinal changes:
Retinal pigmentation and visual field defect are rare. These lesions are reversible after early withdrawal of the drug. If further development, even after the withdrawal of this product, there is still an increased risk. Cases of macular lesions and macular degeneration are reported and may be irreversible.
Patients with retinopathy may have no symptoms in the early stage, or accompanied by paracentral or central dark spots, temporary blind spots, temporal visual field defects and abnormal color vision.
The changes of cornea were as follows
Reports of corneal changes include corneal edema and opacity, which may be asymptomatic or may cause symptoms such as halo, blurred vision or photophobia. These symptoms may be temporary or reversible after withdrawal.
The blurring of vision caused by dysregulation is dose-dependent and may be reversible.
Skin effects
Sometimes skin rashes can occur: pruritus, skin and mucous pigment changes, hair whitening and alopecia have also been reported, these symptoms are usually easy to recover after drug withdrawal.
There have been reports of herpes simplex, including very rare erythema multiforme and Steven Johnson syndrome, toxic epidermal necrolysis, drug eruption with eosinophilic systemic symptoms (DRESS syndrome), photosensitivity and exfoliative dermatitis. Very rare cases of acute generalized exanthematous pustulosis (AGEP) need to be differentiated from psoriasis, although hydroxychloroquine may promote the onset of psoriasis. Fever and leukopenia may be related to hydroxychloroquine. The results usually improve after withdrawal.
Gastrointestinal effects
Gastrointestinal disorders such as nausea, diarrhea, anorexia, abdominal pain and rare vomiting may occur. These symptoms usually disappear immediately after a dose reduction or discontinuation of treatment.
Central nervous system effects
The rare adverse reactions such as dizziness, vertigo, tinnitus, hearing loss, headache, nervousness, emotional instability, psychosis and convulsion were reported.
Neuromuscular effects
Sensory and motor nerve diseases may occur. There are reports of skeletal myopathy or neuromyopathy with progressive weakness and proximal muscle atrophy. My pathy may recover after drug withdrawal, but it will take many months to recover.
Slight sensory changes, inhibition of tendon reflex and abnormal nerve conduction may be observed.
Cardiovascular system impact
Cardiomyopathy (which can lead to heart failure), some cases have reported death.
When cardiac conduction abnormalities (bundle branch block / atrioventricular block) and bilateral ventricular hypertrophy are found, the chronic toxicity of drugs should be suspected. It may recover after withdrawal.
Hematological effects
Bone marrow suppression is rarely reported. Hematological abnormalities such as anemia, aplastic anemia, agranulocytosis, leukopenia and thrombocytopenia have been reported.
Hydroxychloroquine may promote or aggravate porphyria.
·Liver effects:
Some cases of abnormal liver function were reported, and some cases of fulminant liver failure were reported.
·Allergic reaction
Urticaria, angioedema and bronchospasm have been reported.
Metabolic and nutritional system effects
Hypoglycemia may occur with unknown frequency.
Taboo: - patients known to be allergic to 4-chloroquinoline compounds
- patients with prior macular disease of the eye
- children under 6 years old (200mg tablet is not suitable for children weighing less than 35kg)
Matters needing attention: ·Before the treatment of this product, all patients should have ophthalmic examination, including vision sensitivity, ophthalmoscopy, central vision, color sense and fundus examination. Thereafter, it should be checked at least once a year.
·Retinopathy is closely related to drug dosage. The risk of retinal damage is low when the maximum daily dose is no more than 6.5mg/kg body weight. But exceeding the recommended daily dose will significantly increase the risk of retinal toxicity.
The frequency of ophthalmic examination should be increased in patients with the following conditions:
- ideal weight of more than 6.5mg/kg per day. The absolute weight as a drug guidance for obese patients can lead to overdose.
- renal insufficiency;
- the cumulative dosage is more than 200g;
- the elderly;
- impaired visual sensitivity;
If visual impairment (visual sensitivity, color sense, etc.) occurs, stop the drug immediately and closely observe the progress of the abnormal condition of the patient. Even after the treatment has been stopped, retinopathy (and visual impairment) may continue to develop further( See "adverse reactions" section)
Studies have shown that hydroxychloroquine can cause severe hypoglycemia, including loss of consciousness, which may endanger the lives of patients who have received or have not received antidiabetic drugs. Patients who are treated with hydroxychloroquine should be warned of the risk of hypoglycemia and related clinical signs and symptoms. During the treatment with hydroxychloroquine, if hypoglycemia symptoms occur, blood glucose level should be checked, and if necessary, the treatment should be re evaluated.
Among the patients treated with hydroxychloroquine sulfate, a rare case reported suicide.
Cases of heart failure caused by cardiomyopathy have been reported in patients treated with this product, some of which reported death. It is suggested that the signs and symptoms of cardiomyopathy be monitored clinically. This product should be stopped in case of cardiomyopathy. Chronic toxicity of drugs should be considered when cardiac conduction abnormality (bundle branch block / atrioventricular block) and bilateral ventricular hypertrophy are found.
Patients who are taking drugs that may cause eye or skin adverse reactions should use the product with caution. Caution should also be taken when patients with liver or kidney disease, or those who are taking known to affect these organs, and patients with severe gastrointestinal, neurological and blood abnormalities. The plasma hydroxychloroquine level should be estimated in patients with severe impairment of liver and kidney function in order to adjust the dosage.
Although the risk of myelosuppression is low, anemia, aplastic anemia, granulocytopenia, leucopenia and thrombocytopenia have been reported. It is suggested to count the blood fine area regularly. If there is any abnormality, the product should be stopped.
Patients sensitive to quinine, patients with glucose-6-phosphate dehydrogenase defects, those who take hydroxychloroquine can aggravate delayed porphyria, psoriasis patients from dry products seem to increase the risk of adverse skin reactions, and should also use this product carefully.
Patients with rare genetic diseases such as galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption should not take this product.
Children are particularly sensitive to the toxic effects of 4-aminoquinoline; Therefore, the patient is warned to place the product in a place that children cannot reach.
All patients who have been treated for a long time should check skeletal muscle function and tendon reflex regularly. If skeletal muscle function and tendon reflex are reduced, stop the drug.
There are reports of impairment of vision regulation shortly after the treatment. The person who drives and operates the machine should be reminded. If symptoms cannot be self limiting, reduce dose or stop treatment.
Malaria: the treatment of falciparum with resistance to chloroquine is invalid, and it is not effective for Plasmodium vivax, Plasmodium egg and Plasmodium 3 outside the red blood cells, so it cannot prevent infection or recurrence.
Medication for pregnant and lactating women: Hydroxychloroquine can pass through the placenta. There is limited data about the application of hydroxychloroquine in pregnancy. It should be noted that 4-aminoquinoline in the treatment dose is related to central nervous system damage, including ototoxicity (auditory and vestibular toxicity, congenital deafness), retinal hemorrhage and retinitis pigmentation. Therefore, women in pregnancy should avoid the use of hydroxychloroquine unless the potential benefits of treatment are assessed by the doctor greater than the potential risk.
Nursing women should be careful with hydroxychloroquine, because there are a small amount of hydroxychloroquine secreted in human milk, and the toxic effect of 4-aminoquinoline is known in infants.
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